This year’s ISPOR conference theme was “Impacting Innovation, Value, and Healthcare Decision-Making.” As a Gold Sponsor for the event, Axtria hosted a workshop on Social Determinants of Health and presented six posters. Major takeaways from the conference include:
The growth of real-world evidence (RWE) for regulatory submissions and market access – Several presentations discussed innovative approaches for generating RWE, including external control arms and the growth and acceptance of causal inference methods.
Social determinants of health (SDoH) – In Axtria’s workshop, “Does Geography Affect Health?”, the team explored how a new approach that links health outcomes to SDoH at the patient level can reveal powerful insights for action.
Artificial intelligence (AI) and Machine Learning (ML) – ChatGPT, natural language processing (NLP), and AI are revolutionizing the processing of wearable and sensor data to capture clinical and patient-reported outcomes directly, allowing the transformative utilization of ML with large electronic health record (EHR) datasets.
Recent impacts of the Inflation Reduction Act (IRA) on the life sciences industry – Key talking points at the conference included how RWD/RWE will be used and whether the Center for Medicare and Medicaid Services (CMS) will incorporate comparative effectiveness measures in setting the maximum fair price for new drugs.
A Deep Dive Into Key Topics
RWE For Regulatory Submissions, Pricing, And Reimbursement
Just before the main conference, ISPOR RWE Summit 2023 offered an in-depth examination of critical issues surrounding RWE in regulatory, pricing, and reimbursement decisions. Embracing the widespread recognition of the abundance of analytical tools available for RWD analysis, the summit offered insights into data quality, transparency, and fit-for-purpose RWD. The summit also provided a roadmap for the full RWE spectrum, starting with meticulous data selection and protocol design and extending through the execution of research and the subsequent reporting of study findings. The growth in external control arms leveraging RWD was an important topic of discussion.
Axtria’s poster presentations, Real-World Evidence Usage In Regulatory Approvals From USFDA and EMA and The Potential Of Real-World Evidence To Complement Basket Trials For Tissue-Agnostic Drugs Targeting Neurotrophic Tropomyosin-Related Kinase Gene Fusions were well received, engaging conference attendees in in-depth discussions.
Social Determinants of Health
The conference placed significant emphasis on the trending topic of Social Determinants of Health (SDoH). Patient-level SDoH are widely unavailable from many real-world databases. In the absence of individual-level SDoH data, it is possible to draw meaningful insights by integrating patient-level health data with geography-level SDoH. Furthermore, the FDA’s draft guidance for the industry recommended that sponsors develop a diversity plan to enroll representative participants from underrepresented racial and ethnic populations in clinical trials.
Axtria’s team conducted a workshop aimed at highlighting several critical factors in current work with RWE, including:
The growing importance of incorporating SDoH in RWE and HEOR analytics from the regulatory and payer perspectives
Providing industry examples that use SDoH data to understand disparity and improve diversity, equality, and inclusion
Describing appropriate methods for statistical analysis
The workshop was well received, and the audience engaged in thought-provoking panel discussions.
AI/NLP in RWE and HEOR
The conference also drew attention to other trending topics, including the various applications of AI/ML in RWE and HEOR analytics that are currently captivating numerous industries. The transformative work being done by applying ML to EHR datasets has been increasingly frequent in recent years and was of specific interest.
The session “AI Wants to Chat with You; Accept or Ignore?” discussed recent advancements in AI chatbots like ChatGPT. Simultaneously, as researchers venture into the realm of AI and NLP applications, they are developing a more intimate understanding of the essential need for human expertise in the form of data science experts and content/subject matter experts, who play a crucial role in guiding automated analysis and learning processes. Their skills are essential when dealing with unstructured and unprecedented data.
Inflation Reduction Act
One major discussion point was the IRA’s recent effects on the life sciences industry. The IRA is the US government’s 10-year plan to curb inflation, partly by lowering prices on prescription drugs. Key talking points included how RWD/RWE will be used and whether the CMS will use comparative effectiveness measures in setting the maximum fair price for new drugs. Questions around this topic included whether the IRA would slow innovation and lead to a black box scenario for manufacturers. In our opinion, the IRA will continue to trend as a topic of discussion in the times to come.
We hope you find this summary of conference highlights valuable. If you were unable to attend the conference and would like more information on Axtria’s offerings in RWE and HEOR, please feel free to contact us at connect@axtria.
We look forward to attending the ISPOR Europe conference in Copenhagen in November and hope to see you there.
Until next time,